Sealing apparatus and methods of use

Abstract

A system for treating an aneurysm comprises at least a first double-walled filling structure having an outer wall and an inner wall and the filling structure is adapted to be filled with a hardenable fluid filling medium so that the outer wall conforms to the inside surface of the aneurysm and the inner surface forms a generally tubular lumen to provide blood flow. The first filling structure comprises a sealing feature which forms a fluid seal between the filling structure and the aneurysm or an adjacent endograft when the filling structure is filled with the hardenable fluid filling medium, thereby minimizing or preventing blood flow downstream of the seal.

What is claimed is: 
     
       1. A system for treating an aneurysm, said system comprising:
 at least a first double-walled filling structure having an outer wall and an inner wall, wherein the filling structure is adapted to be filled with a hardenable fluid filling medium so that the outer wall conforms to the inside surface of the aneurysm and the inner surface forms a generally tubular lumen extending from a top end of the filling structure to a bottom end of the filling structure along a first longitudinal axis to provide blood flow therethrough, 
 a second double-walled filling structure having an outer wall and an inner wall, wherein the second filling structure is adapted to be filled with a hardenable fluid filling medium so that the outer wall conforms to the inside surface of the aneurysm and the inner surface forms a generally tubular lumen extending from a top end of the filling structure to a bottom end of the filling structure along a second longitudinal axis to provide blood flow therethrough, 
 wherein each of the first and the second filling structure comprises a sealing feature, the sealing features forming a fluid seal between the filling structures and the aneurysm when the first and second filling structures are positioned side-by-side across the aneurysm with the respective top ends positioned in an upstream direction and filled with the hardenable fluid filling medium, thereby minimizing or preventing blood flow downstream of the seal and inhibiting migration of the first and second filling structures, wherein the sealing feature of the first filling structure comprises a portion having a pre-defined first and the sealing feature of the second filling structure comprises a portion having a pre-defined second shape, each of the first and second shapes comprising a vertical cross-section shape of the respective filling structure along the respective longitudinal axis when extending vertically, the vertical cross-section shape having a horizontal width dimension varying along the respective longitudinal axis, wherein the horizontal width dimension of the first pre-defined shape differs from the horizontal width dimension of the second pre-defined shape along a common horizontal axis when the first and second filling structures are aligned in parallel along the respective longitudinal axis extending vertically and the respective top ends and/or bottom ends are aligned horizontally side-by-side, 
 wherein the second shape is complementary to the first shape when the first and second double-walled filling structures are deployed within the aneurysm, the first and second filling structures being positioned adjacent side-by-side across the aneurysm and filled with the hardenable fluid when deployed, such that engagement between the portions having the respective first and second shapes inhibit relative longitudinal movement between the first and second filling structure, 
 wherein the first and second filling structures are separately deliverable and positionable relative to each other along the respective longitudinal axes. 
 
     
     
       2. A system as in  claim 1 , wherein the sealing feature of each of the first and second filling structures is disposed in a neck of the aneurysm when the filling structures are deployed within the aneurysm. 
     
     
       3. A system as in  claim 1 , wherein the sealing feature of each of the first and second filling structures is disposed upstream of the aneurysm. 
     
     
       4. A system as in  claim 1 , wherein the tubular lumen has a substantially circular cross-section perpendicular to the longitudinal cross-section. 
     
     
       5. A system as in  claim 1 , wherein the first filling structure comprises an elliptical cross-section perpendicular to the longitudinal cross-section when filled with the hardenable filling medium. 
     
     
       6. A system as in  claim 1 , wherein the first filling structure is formed by two sheets, an edge of each sheet being sealed together and adapted to withstand a filling pressure of up to 300 mm Hg above normal systolic pressure without bursting. 
     
     
       7. A system as in  claim 1 , further comprising a thrombogenic material. 
     
     
       8. A system as in  claim 7 , wherein the thrombogenic material is selected from the group consisting of polyurethane, polycarbonate, polyester, ePTFE, polyolefin, parylene, gelatin and silicone. 
     
     
       9. A system as in  claim 7 , wherein the thrombogenic material is formed into one of sutures, felts, velours, weaves, knits, hydrogels, foams, coils, sheets and combinations thereof. 
     
     
       10. A system as in  claim 7 , wherein the thrombogenic material is coupled with an outer surface of the first double-walled filling structure. 
     
     
       11. A system as in  claim 7 , wherein the thrombogenic material comprises a thrombogenic drug. 
     
     
       12. A system as in  claim 1 , wherein the inner and outer walls comprise ePTFE. 
     
     
       13. A system as in  claim 12 , wherein the inner and outer walls are at least partially covered with polyurethane. 
     
     
       14. A system as in  claim 1 , wherein the first and second shapes comprise complementary tapers that taper in opposing directions when the first and second filling structures are aligned vertically in parallel along the respective longitudinal axis and the respective top ends and/or bottom ends aligned horizontally side-by-side. 
     
     
       15. A system as in  claim 1 , wherein each of the first shape and second shape varies in width along the first and second longitudinal axes, respectively. 
     
     
       16. A system as in  claim 1 , wherein each of the first shape and second shape varies in width by variation in a distance between the outer wall and the respective longitudinal axis. 
     
     
       17. A system as in  claim 14 , wherein the first shape and second shape taper in opposite directions such that engagement between the outer walls of the first and second filling structure along the complementary tapers inhibit relative movement between the first and second filling structures along their respective longitudinal axis. 
     
     
       18. A system as in  claim 16 , wherein the portion of the first filling structure having the first shape includes substantially the entire first filling structure along the first longitudinal axis and the portion of the second filling structure having the second shape includes substantially the entire second filling structure along the second longitudinal axis. 
     
     
       19. The system of  claim 1 , wherein the respective horizontal widths differ along a common horizontal axis along a substantial part of the portions having the respective first and second sealing features when the first and second filling structures are aligned vertically in parallel along the respective longitudinal axis with the respective top ends and/or bottom ends aligned horizontally side-by-side. 
     
     
       20. The system of  claim 1 , wherein the respective horizontal widths differ along the common horizontal axis along substantially the entire portions having the respective first and second sealing features when the first and second filling structures are aligned vertically in parallel along the respective longitudinal axis with the respective top ends and/or bottom ends aligned horizontally side-by-side. 
     
     
       21. A system for treating an aneurysm, said system comprising:
 at least a first double-walled filling structure having an outer wall and an inner wall, wherein the filling structure is adapted to be filled with a hardenable fluid filling medium so that the outer wall conforms to the inside surface of the aneurysm and the inner surface forms a generally tubular lumen extending from a top end of the filling structure to a bottom end of the filling structure along a first longitudinal axis to provide blood flow therethrough, 
 a second double-walled filling structure having an outer wall and an inner wall, wherein the second filling structure is adapted to be filled with a hardenable fluid filling medium so that the outer wall conforms to the inside surface of the aneurysm and the inner surface forms a generally tubular lumen extending from a top end of the filling structure to a bottom end of the filling structure along a second longitudinal axis to provide blood flow therethrough, 
 wherein each of the first and the second filling structure comprises a sealing feature, the sealing features forming a fluid seal between the filling structures and the aneurysm when the first and second filling structures are positioned side-by-side across the aneurysm with the respective top ends positioned in an upstream direction and filled with the hardenable fluid filling medium, thereby minimizing or preventing blood flow downstream of the seal and inhibiting migration of the first and second filling structures, wherein the sealing feature of the first filling structure comprises a portion having a pre-defined first shape and the sealing feature of the second filling structure comprises a portion having a pre-defined second shape, wherein the first and second shapes are adapted such that, when each of the first and second filling structures are expanded to full capacity and aligned in parallel along their respective longitudinal axes extending vertically and the respective top ends and/or bottom ends are aligned side-by-side horizontally, the portion having the first pre-defined shape comprises an upwards facing surface and the portion having the second-predefined shape comprises a downwards facing surface along a common horizontal plane such that, when the respective filling structures are deployed adjacent and side-by-side across the aneurysm, engagement between the upwards facing surface and the downwards facing surface facilitates sealing and inhibits longitudinal movement between the first and second filling structures, 
 wherein the first and second filling structures are separately deliverable and positionable relative to each other along the respective longitudinal axes. 
 
     
     
       22. A system as in  claim 1 , wherein each of the complementary shapes of the first and second filling structures has a horizontal cross-section that is symmetrical about the respective longitudinal axis.